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NCT ID: NCT04815096 Recruiting - Covid19 Clinical Trials

Imaging Immune Activation in COVID-19

Start date: April 15, 2021
Phase: Early Phase 1
Study type: Interventional

This is a single center, single arm exploratory imaging study involving up to two intravenous microdoses of [18F]F-AraG (the second tracer dose is optional) followed by whole-body PET-CT imaging in participants with convalescent COVID-19. Up to 20 participants will be enrolled over an accrual period of approximately 24 months. Each participant will undergo one PET-CT scan following 50 +/- 10 minutes uptake following a single bolus injection of [18F]F-AraG in order to determine the tissue distribution of tracer in pariticpants with recent SARS-CoV-2 infection. A second optional [18F]F-AraG dose and PET-CT will be offered approximately 4 months following the initial imaging time point.

NCT ID: NCT04816149 Recruiting - Suicide Clinical Trials

Treatment for Relationships and Safety Together

TR&ST
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Suicide prevention is the top clinical priority for VA/DoD. Suicide is one of the leading causes of death in the United States and worldwide with suicide rates among U.S. military Veterans doubling (27.7 per 100,000) the rate of civilian levels. Despite a rise in prevention efforts, rates have continued to increase. Theories of suicide and rehabilitation psychology stress the importance of the person-environment interaction in contributing to one's disability experience. Several studies have found that the most frequent situation precipitating suicide was a problem with a romantic partner. In contrast, people with higher relationship satisfaction are less likely to have suicidal thoughts. Prevention of suicide in high risk Veterans is of vital importance and the quality of one's intimate relationship is an understudied intervention target for suicide prevention. Despite the fact that VA/DoD recommend and Veterans desire treatments that involve family members, currently no couple-based suicide-specific interventions exist. The goals of this CDA-II proposal are to refine and pilot a novel suicide-specific couple-based intervention: Treatment for Relationships and Safety Together (TR&ST). TR&ST adapts an evidence-based intervention for suicide, Brief Cognitive Behavioral Therapy (BCBT) for Suicide, to be dyadically focused and integrates Cognitive Behavioral Couple Therapy (CBCT) skills. The proposed 5-year study consists of two phases. Phase 1: treatment refinement with 12 couples (N=24) and Phase 2: pilot Randomized Controlled Trial (RCT) of TR&ST compared to VA Standard Suicide Intervention, which will involve suicide risk assessment, VA safety planning, Suicide Prevention Coordinator (SPC) follow-up, and referral to outpatient mental health with 60 couples (N=120). The intervention period is 11-weeks and the entire study period is approximately 7 months. Couples in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment. The primary outcome to be evaluated is change in severity of suicidal thoughts. Secondary outcomes concern changes in interpersonal functioning theorized to influence suicidal thoughts and behavior.

NCT ID: NCT04822649 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF)

Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The correlation of coronary microvascular function and body composition with cardiopulmonary exercise capacity will be assessed in patients with heart failure with preserved ejection fraction.

NCT ID: NCT04823091 Recruiting - Clinical trials for T Cell Non-Hodgkin Lymphoma

Anti-CD7 CAR-Engineered T Cells for T Lymphoid Malignancies Malignancies

Start date: April 15, 2021
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD7 chimeric antigen receptor(CAR)-modified T cells(CAR7-Ts) in patients with relapsed or refractory T lymphoid malignancies.

NCT ID: NCT04830423 Recruiting - Knee Osteoarthritis Clinical Trials

The Effectiveness of Ultrasound Guided Ozone (O2-O3) Injection With Knee Osteoarthritis

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Knee ostheoarthritis (KOA) is a common disabling and degenerative disease leading to painful joints, articular stiffness, and decreased function. The mechanism of the ozone of relieving the pain and improving the knee function is through inhibiting the inflammation reaction in the KOA directly. Actually, the ozone intra-articular injection had been used to relieve the pain caused by KOA. The aim of this study is to evaluate the effect of intra-articular injection of medical ozone given into the knee of the osteoarthritis patients, and to compare it with intra-articular steroid injection and to investigate the effectiveness of ozone and steroid the job to determine the superiority of the injections to each other.

NCT ID: NCT04830774 Recruiting - COVID-19 Clinical Trials

Natural History of COVID-19-Related Atrial Fibrillation

unCOVer-AF
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The unCOVer-AF prospective, multicenter registry aims at determining the natural history of atrial fibrillation (AF) via continuous cardiac rhythm monitoring in patients with a first arrhythmic episode during COVID-19 hospitalization.

NCT ID: NCT04831970 Recruiting - Radiation Toxicity Clinical Trials

POst-Prostatectomy Ablative Radiation Therapy

POPART
Start date: April 15, 2021
Phase:
Study type: Observational

The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility. The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute (< 90 days from the end of treatment) and late (> 90 days) setting.

NCT ID: NCT04831983 Recruiting - Prostate Cancer Clinical Trials

ABlative Radiotherapy (for) Unfavorable Prostate Tumors

ABRUPT
Start date: April 15, 2021
Phase:
Study type: Observational

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines.

NCT ID: NCT04832230 Recruiting - Acoustic Trauma Clinical Trials

Study of Diagnostic Biomarkers of Acute Acoustic Trauma

BIOTSA
Start date: April 15, 2021
Phase:
Study type: Observational

Every year, more than two thousand acute acoustic trauma occur in France, equally between the military and the civilian environment. Currently, acute acoustic trauma is a pathology with no specific validated treatment, and it is the cause of many handicapping situations. Improving the future of patients requires a better understanding of the neurophysiological mechanisms of noise-induced hearing impairment. They are multiple and pure tone audiometry, the only reference examination, does not allow to differentiate them. Moreover, in the aftermath of acute acoustic trauma, pure tone audiometry tends to improve spontaneously, but this recovery is misleading, as a number of studies in animals have shown that irreversible lesions remain. The hypothesis of this study is that it is possible to identify new entities, specific to the type of cochlear lesions, in order to clarify the diagnosis of acute acoustic trauma. These entities will be identified by the evaluation of noise-induced hearing impairment via a combination of molecular (proteomic and genomic), physiological and behavioral data. These diagnostic details may then be used to improve prevention or therapy.

NCT ID: NCT04833413 Recruiting - Insulin Clinical Trials

Regimen Switch After Intensive Insulin Therapy

Start date: April 15, 2021
Phase:
Study type: Observational

Insulin intensive therapy have traditionally been considered a sequential therapy in type 2 diabetes last choice, a number of guidelines and consensus recommendations insulin intensive therapy can be as obvious hyperglycemia in patients with newly diagnosed T2DM part of a line, a subset of patients after insulin intensive treatment target often need to change to other treatments, especially for senile diabetes patients, due to its self management ability, simplify the insulin solution is more urgent. Current clinical guidelines do not provide specific clinical guidance, such as the timing and method of switch after initial insulin intensive therapy. The purpose of this study was to explore the timing, suitable population and conversion methods of insulin regimens after treatment.